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Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Health Highlights: May 26, 2017

Posted 3 days ago in Medical

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: German Parents Who Don't Have Children Vaccinated Will Face Fines Parents who don't have their children vaccinated will face fines, the German health minister says. The fines of up to $2,806 are necessary because of a measles epidemic, Hermann Grohe told the daily Bild, BBC News reported. "Continuing deaths...

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Meth Addicts' Hearts May Improve If They Quit

Posted today in Medical

MONDAY, May 29, 2017 -- Methamphetamine users who quit the drug may get a break: New research suggests it's possible to reverse heart damage with proper medical treatment. Research has previously linked meth use to heart problems that can contribute to death. But it hadn't been clear if stopping the drug use resulted in better heart health. The small study found that after discontinuing methamphetamine use,...

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Brush Up on Swim Safety for Summer

Posted today in Medical

MONDAY, May 29, 2017 -- Before your family pulls out their swimsuits this Memorial Day, brush up on water safety, for your kids' sake. Here are some tips from the American Academy of Pediatrics on how to make sure children are protected while they spend their summers in or around pools, lakes and oceans: Don't leave kids alone in the water, and make sure a responsible adult is watching them closely. "Touch...

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To Lose Weight, Start With Dairy Swaps

Posted today in Medical

MONDAY, May 29, 2017 -- Losing weight comes down to simple arithmetic: Eat fewer calories than you burn off. Here's a good way you can accomplish this without going hungry. Switch out high-calorie foods for low-calorie options to cut calories without cutting portion sizes. Dairy food is a good place to start, according to the U.S. Department of Agriculture. If you're still using whole milk and cream, make gradual...

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Lawn Mowers Are Risky Business for Kids

Posted today in Medical

MONDAY, May 29, 2017 -- Though mowing lawns has long been a source of income for young people, experts warn that lawn mowers pose a major safety risk to children. "We need to remind people that these are dangerous machines, and the consequences are devastating," Mariano Garay, a fourth year medical student at Penn State College of Medicine, said in a school news release. Garay has studied lawn mower injuries in...

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FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature

Posted 7 days ago in New Drug Approvals

May 23, 2017 -- The U.S. Food and Drug Administration today granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric...

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Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis

Posted 7 days ago in New Drug Approvals

PARIS and TARRYTOWN, N.Y., May 22, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as...

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FDA Approves Actemra (tocilizumab) Subcutaneous Injection for Giant Cell Arteritis

Posted 8 days ago in New Drug Approvals

May 22, 2017 -- The U.S. Food and Drug Administration today expanded the approved use of subcutaneous Actemra (tocilizumab) to treat adults with giant cell arteritis. This new indication provides the first FDA-approved therapy, specific to this type of vasculitis. “We expedited the development and review of this application because this drug fulfills a critical need for patients with this serious disease who had l...

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FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Posted 12 days ago in New Drug Approvals

KENILWORTH, N.J.--(BUSINESS WIRE) May 18, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved two new indications for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, Keytruda ...

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FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis

Posted 12 days ago in New Drug Approvals

May 17, 2017 -- The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from...

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FDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests

Posted 12 days ago in Pharma Industry News

May 17, 2017 -- The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been...

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FDA Authorizes Use of New Device to Treat Esophageal Birth Defect in Babies

Posted 2 weeks ago in Pharma Industry News

May 12, 2017 -- The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their esophagus, called esophageal atresia. An estimated 1 in every 2,500 babies in the U.S. is born with esophageal atresia. Babies with this condition cannot feed normally,...

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Monthly News Roundup - April 2017

Posted 4 weeks ago in Pharma Industry News

Takeda Announces FDA Accelerated Approval of Alunbrig The US Food and Drug Administration (FDA) has approved once-daily oral Alunbrig (brigatinib) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). In the pivotal Phase 2, open-label ALTA study which enrolled 222 patients, the...

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Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA

Posted 4 weeks ago in New Drug Applications

Paris, France and Tarrytown, New York - April 28, 2017 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted the resubmission of Biologics License Application for Kevzara (sarilumab) as a Class I response with a two month review timeline. Per the Prescription Drug User Fee Act (PDUFA), the new target action date is May 22, 2017. Kevzara is an...

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Rigel Announces Tavalisse as Proprietary Name for Fostamatinib in the United States

Posted 4 weeks ago in New Drug Applications

SOUTH SAN FRANCISCO, Calif., April 27, 2017 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name Tavalisse™ for the company's investigational product candidate, fostamatinib disodium, an oral spleen tyrosine kinase (SYK) inhibitor. In addition, Rigel has applied to the U.S. Patent and Trademark O...

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Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Intravitreal Sirolimus (DE-109) in the Treatment of Non-Infectious Uveitis of the Posterior Segment

Posted 4 weeks ago in New Drug Applications

April 25, 2017, Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter, “Santen”), a specialized ophthalmology company headquartered in Osaka, Japan, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravitreal (IVT) sirolimus (440 µg), development code DE-109, for the treatment of non-infectious uveitis of the posterior segment (NI...

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PTC Therapeutics Completes Acquisition of Emflaza for the Treatment of Duchenne Muscular Dystrophy in the U.S.

Posted 5 weeks ago in New Drug Applications

SOUTH PLAINFIELD, N.J., April 20, 2017 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced it has completed its acquisition of all rights to Emflaza™ (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD) in the U.S. Execution of the asset purchase agreement setting forth the terms of the acquisition was announced on March 16, 2017. "We are pleased the acquisition was completed a...

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TherapeuticsMD Provides Additional Information on TX-004HR Regulatory Update

Posted 5 weeks ago in New Drug Applications

BOCA RATON, Fla.--(BUSINESS WIRE)--Apr. 19, 2017-- TherapeuticsMD, Inc. (NYSE MKT: TXMD), an innovative women’s healthcare company, today announced that, based on continued correspondence with the U.S. Food and Drug Administration (FDA), the Company expects that the FDA will finalize an action on the New Drug Application (NDA) for TX-004HR, an investigational bio-identical 17β-estradiol vaginal softgel capsule for th...

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FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients

Posted 7 weeks ago in Pharma Industry News

April 7, 2017 -- The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral...

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FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions

Posted 7 weeks ago in Pharma Industry News

April 6, 2017 -- The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or ...

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Agile Therapeutics Reports Additional Phase 3 SECURE Study Results Relating to Twirla

Posted 3 weeks ago in Clinical Trials

PRINCETON, N.J., May 06, 2017 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (NASDAQ:AGRX), a women's healthcare company, today announced the presentation of additional results of its Phase 3 SECURE trial of its investigational low-dose combination hormone contraceptive patch, Twirla (AG200-15). Anita Nelson, MD, Professor and Chair of Obstetrics and Gynecology at the College of Osteopathic Medicine of the Pacific,...

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Aeterna Zentaris Announces that ZoptEC Phase 3 Clinical Study of Zoptrex™ Did Not Achieve its Primary Endpoint

Posted 4 weeks ago in Clinical Trials

CHARLESTON, S.C.--(BUSINESS WIRE) May 1, 2017 --Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the “Company”) today announced that the ZoptEC Phase 3 clinical study of Zoptrex™ (zoptarelin doxorubicin) in women with locally advanced, recurrent or metastatic endometrial cancer did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patie...

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Tesaro Announces Submission of Investigational New Drug Application for Anti-LAG Antibody TSR-033 to the U.S. FDA

Posted 4 weeks ago in Clinical Trials

WALTHAM, Mass., May 01, 2017 (GLOBE NEWSWIRE) -- Tesaro, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the submission of an Investigational New Drug (IND) Application for TSR-033 to the U.S. Food and Drug Administration. TSR-033 is a monoclonal antibody targeting LAG-3. "The IND for TSR-033 is the third application from our immuno-oncology franchise to be submitted to the FDA...

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Pfizer’s Next-Generation ALK/ROS1 Inhibitor, Lorlatinib, Granted Breakthrough Therapy Designation from FDA for ALK-Positive Metastatic Non-Small Cell Lung Cancer

Posted 4 weeks ago in Clinical Trials

April 27, 2017 -- Pfizer Inc. today announced that its investigational next-generation ALK/ROS1 tyrosine kinase inhibitor, lorlatinib, was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), previously treated with one or more ALK inhibitors. Enacted as...

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The Medicines Company and Alnylam Pharmaceuticals Announce Agreement with FDA on Phase III Clinical Program for Inclisiran

Posted 4 weeks ago in Clinical Trials

PARSIPPANY, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 26, 2017-- The Medicines Company (NASDAQ:MDCO) and Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) today announced that The Medicines Company has agreed with the U.S. Food and Drug Administration (FDA) on plans for the Phase III clinical program for inclisiran, which is designed to support the submission of a New Drug Application (NDA). The Company has...

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